Westwood Laboratories, LLC. – FDA 483, Apr 5, 2022

Westwood Laboratories, Inc. in Azusa, CA, a contract manufacturer, received a Form 483 with four observations, three of which were repeats. The inspection revealed significant deficiencies in environmental monitoring, data integrity for computer systems, incomplete batch production records, and inadequate change control procedures. These issues indicate a systemic lack of adherence to Good Manufacturing Practices.